PTAB

PGR2023-00051

KInderFarms LLC v. Genexa Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pharmaceutical Syrup Formulation or Suspension
  • Brief Description: The ’795 patent discloses oral pharmaceutical syrup formulations for delivering active pharmaceutical ingredients (APIs), specifically acetaminophen. The core concept involves using agave syrup as a natural sweetener and vehicle to suspend the API, purportedly to mask its unpleasant taste and provide a healthier alternative to formulations with artificial ingredients.

3. Grounds for Unpatentability

Ground 1: Claims 1-24 are obvious over FR458 in view of the ’4666 Patent and/or WO133.

  • Prior Art Relied Upon: FR458 (French Publication 2,993,458), `’4666` Patent (Patent 4,684,666), and WO133 (WO 95/00133).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the primary reference, FR458, discloses the core of the invention by teaching a liquid pharmaceutical preparation for oral administration based on organic agave syrup. Specifically, FR458’s Example 1 describes a suspension containing paracetamol (acetaminophen), agave syrup, purified water (a diluent), citric acid (an acidic preservative), and natural flavoring. To the extent FR458 does not explicitly disclose the claimed viscosity, Petitioner asserted that the ’4666 Patent and WO133 remedy this. Both secondary references address the known problem of creating stable, taste-masked oral analgesic suspensions and teach controlling viscosity to achieve this. The ’4666 Patent discloses a viscosity range of 100-3000 centipoise, and WO133 teaches a range of 200-900 centipoise, both of which overlap with and render obvious the claimed viscosity of less than 1500 centipoise.
    • Motivation to Combine: A POSITA would combine these references to solve the well-known problem of creating a palatable and stable liquid analgesic for patients who have difficulty swallowing tablets. Petitioner contended that a POSITA, starting with FR458's agave-based acetaminophen formulation, would look to well-established art like the ’4666 Patent and WO133 for guidance on optimizing the formulation’s physical properties, such as viscosity, for improved stability and mouthfeel. The shared goal of developing effective oral analgesics provides a strong motivation to integrate these teachings.
    • Expectation of Success: Petitioner argued a POSITA would have a reasonable expectation of success because the combination involves applying conventional formulation techniques (viscosity control) from the ’4666 Patent and WO133 to a known base formulation (agave/acetaminophen) from FR458. The components would be expected to perform their known functions predictably.

Ground 2: Claims 1-17 are obvious over WO742 in view of the ’4666 Patent and/or WO133.

  • Prior Art Relied Upon: WO742 (WO 2012/018742), ’4666 Patent (Patent 4,684,666), and WO133 (WO 95/00133).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground presented an alternative primary reference, WO742, which Petitioner argued explicitly discloses compositions with various APIs, including acetaminophen, suspended in agave nectar for oral administration. WO742 discusses using agave nectar as a preferred carrier for syrups and suspensions to replace artificial sweeteners. Similar to Ground 1, Petitioner asserted that the ’4666 Patent and WO133 provide the necessary teachings on optimizing viscosity for stability and palatability in oral analgesic suspensions. The combination of WO742’s agave/acetaminophen base with the viscosity parameters taught in the secondary references allegedly discloses all limitations of the challenged claims.
    • Motivation to Combine: The motivation argument mirrored that of Ground 1. A POSITA seeking to develop a commercial agave-based acetaminophen product as taught by WO742 would naturally consult prior art like the ’4666 Patent and WO133 to implement best practices for controlling viscosity, ensuring stability, and masking taste. Furthermore, Petitioner noted that antitussives like dextromethorphan (taught in WO742) are often combined with analgesics like acetaminophen, making the combination of these references particularly intuitive.
    • Expectation of Success: Success was expected because the combination merely applies established principles of suspension formulation to the specific agave-based vehicle taught in WO742, using well-known ingredients for their intended purposes.

  • Additional Grounds: Petitioner asserted an alternative ground that claims 1-24 are indefinite under 35 U.S.C. §112 based on the use of subjective terms "palatable" and "stable" without sufficient guidance in the specification, and ambiguity in the scope of the phrase "consisting essentially of."

4. Key Claim Construction Positions

  • "palatable" (claims 1-6, 18-24): Petitioner argued this term should be construed as having an acceptable and not unpleasant taste. The petition contended that if the Patent Owner asserts the prior art formulations do not meet this limitation, the term becomes fatally indefinite under §112 because the specification provides no objective standard for measurement.
  • "stable" (claims 7-18): The petition asserted that this term means the formulation is suitable for administration for its entire shelf life. However, because the patent provides no disclosure on how to determine stability, Petitioner argued this term is also indefinite if used to distinguish over the prior art.
  • "consisting essentially of" (claims 18-24): Petitioner argued that this transitional phrase requires clarity on what unlisted ingredients materially affect the invention’s properties. The petition asserted that the ’795 patent's specification is ambiguous, suggesting a preference for natural ingredients while also permitting artificial flavors, leaving a POSITA uncertain about the scope of the claim.

5. Relief Requested

  • Petitioner requested institution of a Post-Grant Review, a final determination that claims 1-24 of the ’795 patent are unpatentable under 35 U.S.C. §103 and/or §112, and cancellation of those claims.